On 12 June 2015, the US Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v Sequenom, Inc. finding that Sequenom’s method claims in U.S. Patent No. 6,258,540 for detecting paternally-inherited cell-free fetal DNA (“cffDNA”) in maternal plasma or serum were not directed to patent eligible subject matter, and therefore invalid.
For a bit of background, the technology at issue is non-invasive prenatal diagnosis of sex determination, blood typing, other genetic disorders (including Down Syndrome), and detection of pre-eclampsia using a simple blood test that reduces or eliminates the need for sampling from the fetus or placenta (which incur risks to both mother and child). Sequenom Inc. is the exclusive licensee of U.S. Patent No. 6,258,540.
The claims of the patent are based on a breakthrough discovery by the inventors that cffDNA is present in maternal plasma or serum, that was previously routinely discarded as medical waste, and their subsequent implementation of a method for detecting a small fraction of cffDNA in the maternal plasma or serum.
In making its decision, the Court applied the two-part test as set forth in Mayo v Prometheus, and held that the method claims in the patent “begins and ends with a natural phenomenon”, and that the additional elements in the method steps “individually and as an ordered combination” were not enough “to supply an inventive concept”.
To rub salt into the wound, the Court also stated:
“While Drs. Lo and Wainscoat’s discovery regarding cffDNA may have been a significant contribution to the medical field that alone does not make it patentable. We do not disagree that detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science. But even such valuable and contributions can fall short of statutory patentable subject matter, as it does here”.
This decision, which shows the sweeping impact the Supreme Court’s decision in Mayo v Prometheus has had on the patent eligibility of diagnostic methods, further limits the possibility of securing diagnostic patents in the US and is likely to have devastating effects on the diagnostic and personalized medicine industry.
Australia
Unlike in the US, there is no recent Australian decision (e.g. similar to Mayo v Prometheus or the present decision) that impacts negatively on the patentability of diagnostic claims. To be considered patentable in Australia, diagnostic claims must be for “a manner of manufacture” within the meaning of section 18(1)(a) of the Patents Act. In Australia, the general test for patentable subject matter is that an invention is patentable (i.e. a manner of new manufacture) if it provides something that is industrially useful or provides an “artificially-created state of affairs” in a field of economic significance. This test was described in the leading Australian decision, National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, “NRDC”. These principles have been consistently applied ever since, and there is now a large body of Australian case law illustrating their operation.
In general, diagnostic claims are considered to be directed to an “artificially-created state of affairs”. That is, they are man-made processes that produce useful and concrete results, e.g. a method that includes physical/technical steps of, for example, isolating a sample, measuring the expression levels of a panel of biomarkers (proteins/nucleic acids), and determining whether an individual will or will not benefit from/respond to a particular therapy based on the individual’s specific expression profile/genetic make-up.
Thus, at least for the foreseeable future, in Australia, we expect patent applications to continue to be filed and granted in respect of many diagnostic inventions, subject to the usual requirements of novelty, inventive step, utility etc.